<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>20859760005015</udiDi>
    <basicUdiDi>0859760005PMV005AN</basicUdiDi>
    <tradeName>PASSY-MUIR™ TRACHEOSTOMY &amp; VENTILATOR SWALLOWING AND SPEAKING VALVE PMV™ 005 (white)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Passy-Muir, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002288</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PHONATION VALVES FOR TRACHEOSTOMY NOT FOR VENTILATOR USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PMV 005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:57:44.553Z</lastUpdated>
  </row>
  <row>
    <udiDi>20859760005022</udiDi>
    <basicUdiDi>0859760005PMV007AS</basicUdiDi>
    <tradeName>PASSY-MUIR™ TRACHEOSTOMY &amp; VENTILATOR SWALLOWING AND SPEAKING VALVE PMV™ 007 (Aqua Color™)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Passy-Muir, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002288</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PHONATION VALVES FOR TRACHEOSTOMY NOT FOR VENTILATOR USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PMV 007</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:57:44.522Z</lastUpdated>
  </row>
  <row>
    <udiDi>20859760005039</udiDi>
    <basicUdiDi>0859760005PMV2020JA</basicUdiDi>
    <tradeName>PASSY-MUIR™ LOW PROFILE TRACHEOSTOMY SWALLOWING AND SPEAKING VALVE PMV™ 2020 (clear)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Passy-Muir, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002288</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PHONATION VALVES FOR TRACHEOSTOMY NOT FOR VENTILATOR USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PMV 2020</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:57:44.476Z</lastUpdated>
  </row>
  <row>
    <udiDi>20859760005060</udiDi>
    <basicUdiDi>0859760005PMV2000J4</basicUdiDi>
    <tradeName>PASSY-MUIR™ LOW PROFILE TRACHEOSTOMY &amp; VENTILATOR SWALLOWING AND SPEAKING VALVE PMV™ 2000 (clear)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Passy-Muir, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002288</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PHONATION VALVES FOR TRACHEOSTOMY NOT FOR VENTILATOR USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PMV 2000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:57:44.427Z</lastUpdated>
  </row>
  <row>
    <udiDi>20859760005084</udiDi>
    <basicUdiDi>0859760005PMA2000AV</basicUdiDi>
    <tradeName>Passy-Muir™ Valve Oxygen Adapter (PMA™ 2000)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Passy-Muir, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002288</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PHONATION VALVES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PMA 2000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:57:44.360Z</lastUpdated>
  </row>
  <row>
    <udiDi>20859760005145</udiDi>
    <basicUdiDi>0859760005PMV2001J6</basicUdiDi>
    <tradeName>PASSY-MUIR™ LOW PROFILE TRACHEOSTOMY &amp; VENTILATOR SWALLOWING AND SPEAKING VALVE PMV™ 2001 (Purple Color™)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Passy-Muir, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002288</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PHONATION VALVES FOR TRACHEOSTOMY NOT FOR VENTILATOR USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PMV 2001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:57:44.316Z</lastUpdated>
  </row>
</eudamedExport>